The Toxic Substances Control Act (TSCA) is the federal gap-filling chemical control law regulating chemical substances used in applications other than food, drugs, cosmetics, and pesticides, and other uses that are regulated by other federal authorities. Chemical product innovators need to understand how TSCA, significantly amended in 2016, applies to biomass starting material, including industrial microorganisms (such as algae), intermediates, and commercial products, and build TSCA compliance into business timelines and budgets. Doing so will better assure uninterrupted business operations and consistent TSCA compliance.

Imagine receiving a certified letter from the US Environmental Protection Agency (EPA) announcing that it plans to conduct an audit of your company’s facility in two weeks. The audit will focus on your company’s compliance obligations as a chemical manufacturer under the Toxic Substances Control Act (TSCA). Would you be prepared or are you unsure of what TSCA is and whether it applies to you? This article explains how TSCA applies to biobased chemicals and how nomenclature and chemical identity can impact commercialization.

In the second installment of this series, I wrote about how the Toxic Substances Control Act (TSCA) regulates products across a manufacturing process, from feedstock to product. In this last installment, I present options for updating TSCA and the related implementing regulations to put novel, biobased chemistry on an even footing with incumbent products and processes that were grandfathered in as part of the original TSCA Inventory.

The key is to find a way to level the field without compromising the U. S. Environmental Protection Agency’s (EPA) mission and authority to protect human health and the environment.

Bioeconomy companies recognize that their products are subject to a variety of federal chemical regulations, especially if they sell food, food additives, cosmetics, or other products regulated by the U.S. Food and Drug Administration (FDA). Unfortunately, companies may not recognize all the ways that the U.S. Environmental Protection Agency (EPA) regulates bioproducts, perhaps because of the understandable focus on the Clean Air Act (CAA) and the various programs under that authority: Renewable Fuel Standard, fuel additive registration, or other CAA submissions. TSCA also applies to bioproducts used in industrial, commercial, and most consumer products, including fuels. TSCA reporting requirements are in addition to, and separate from, CAA reporting.

The Oil Price Information Network (OPIS) spoke with BRAG's  Richard E. Engler, Ph.D. , Senior Policy Advisor with Bergeson & Campbell, P.C., regarding the application of the Toxic Substances Control Act (TSCA) to oils made from algae feedstocks and other non-traditional bio-materials.  The resulting article in the OPIS Ethanol & Biodiesel Newsletter is reprinted here with permission from OPIS. 

Lynn L. Bergeson, Charles M. Auer, and R. David Peveler published an article appearing in the October 2012 issue of Industrial Biotechnology. The article discusses how the Toxic Substances Control Act (TSCA) applies to biobased chemicals, and suggests strategies for industrial stakeholders to ensure the successful introduction and marketing of biobased chemical products.